Renin Angiotensin Aldosterone System In Septic Kids

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

74 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-24

Study Completion Date

2025-06-01

Brief Summary

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Prospective observational cohort study; pediatric sepsis vs. healthy pediatric subjects and pediatric sepsis with acute kidney injury (AKI) vs without AKI.

Blood samples and renal ultrasound will be collected on sequential days for septic subject and one time for the healthy patients.

Enzyme-linked immunosorbent assays (ELISA) with be run on serum plasma to compare the renin-angiotensin-aldosterone system (RAAS) between groups.

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Detailed Description

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Prospective observational cohort study; pediatric sepsis vs. healthy pediatric subjects and pediatric sepsis with AKI vs without AKI.

Powered to collect 74 patients total (37 sepsis,37 healthy) with enrollment ratio 1:1 and expected different of 50% in renin levels, this provides 80% power at an alpha of 0.05.

Sepsis identified as pediatric Sequential Organ Failure Assessment (pSOFA) \>/= 2 + infection and/or Phoenix sepsis criteria.

Collecting blood samples on subsequent days of hospitalization. For healthy patients, a one-time blood draw will be obtained .

Renal ultrasound will be performed on day 1, 2 and 3 of hospitalization.

Blood will be collected and plasma stored at -80 degrees Celsius.

Plasma thawed in batches and ELISAs for RAAS components.

Demographic data will be collected.

Conditions

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Sepsis Acute Kidney Injury Due to Sepsis Acute Kidney Injury (Nontraumatic)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pediatric Septic

1 day -18 year olds admitted to the ICU meeting criteria for sepsis define as pSOFA \>/= 2 and/or Phoenix score.

No interventions assigned to this group

Healthy

1 day - 18 year old; healthy outpatient

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* pediatric patients age 1 days - 18 years old with sepsis or age 1 day - 18 years and healthy.

Exclusion Criteria

* -pre-existing end stage renal disease (ESRD), chronic renal failure (CRF), home use of angiotensin converting enzyme inhibitor(ACE) or angiotensin receptor blocker(ARB) medications, pre-existing congestive heart failure (CHF), and unrepaired congenital heart disease

Minimum Eligible Age

1 Day

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes